This Month’s Focus: Quality, Validation & Regulatory Compliance
Using fundamental powder properties to optimize flowability
Many methods of measuring powder flowability aren’t predictive and can’t be used to select or design the optimal hopper or bin. Shear cells offer a better approach. This article details how to use them to quantify flow behavior and to design vessels that ensure reliable flow.
Using low-content active ingredients as an indicator of overall blend and tablet uniformities
This article describes the results of blending uniformity studies of a tablet formulation comprising 18 active ingredients, some of which are present in very small amounts. Testing to determine whether all the ingredients are present in the stated amounts would be time consuming and expensive. However, if the low-content active ingredients are uniform in the final blend and in the tablets, then it may be reasonable to assume that the other actives are uniform, too.
A look into the world of cannabinoid formulation
The cannabis industry exists in a Wild West environment, where state law-abiding scientists and fringe characters operate under a variety of conflicting regulations. This article describes that world and provides advice to formulators on the science of developing medicinal cannabinoid products.
Back Page: What does a validation expert do and why do I need one?
Although it’s a regulatory requirement, the FDA only outlines how to perform validation.
Spotlight on Nutraceuticals: Ten questions to ask a contract manufacturer—and yourself—about liquid-filled capsules
Liquid-filled capsules continue to attract dietary supplement consumers and product developers. More often than not, nutraceutical product developers outsource the manufacture of these dosage forms. This article discusses several factors you and your contract manufacturer should consider when developing dietary supplements as liquid-filled capsules.
The evolution of on-dose product identification
On-dose identification enhances patient safety and differentiates your product. This article reviews traditional methods of adding identifiers to tablets and capsules and discusses new technologies that will increase safety, protect the supply chain, and meet manufacturers’ business needs.
Eye on Excipients: On-dose product identification
This edition of the column discusses how porous silica provides on-dose product identification and improves patient compliance with targeted, sustained drug release.
Annual Buyer’s & Reference Guide
January: Capsule Filling
June: Solid Dosage Sourcebook
July: Excipients & Formulation
October: Quality, Validation & Regulatory Compliance
November: Annual Buyer’s Guide
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2. Multi-layer Tabletting
2. Powder Transfer & Containment
2. Mixers & Blenders
2. Tablet & Capsule Identification